Formulary
Ustekinumab: Indications, Dosing, Side Effects and Interactions
Ustekinumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Ustekinumab: Indications, Dosing, Side Effects and Interactions
Ustekinumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Plaque psoriasis (under expert supervision)**
- **Adult** (By Subcutaneous Injection): (body-weight 101 kg and above) Initially 90 mg, then 90 mg after 4 weeks, then 90 mg every 12 weeks, consider discontinuation if no response within 28 weeks.
**Psoriatic arthritis (under expert supervision)**
- **Adult** (By Subcutaneous Injection): Initially 45 mg, then 45 mg after 4 weeks, then 45 mg every 12 weeks, higher doses of 90 mg may be used in patients with body-weight over 100 kg; consider discontinuation if no response within 28 weeks.
**Plaque psoriasis (under expert supervision) for ustekinumab**
- **Child 6-17 years (body-weight up to 60 kg)** (By subcutaneous injection): Initially 750 micrograms/kg, then 750 micrograms/kg after 4 weeks, then 750 micrograms/kg every 12 weeks, consult product literature for advice on calculating volume of injection to be given, consider discontinuation if no response within 28 weeks.
- **Child 6-17 years (body-weight 60-100 kg)** (By subcutaneous injection): Initially 45 mg, then 45 mg after 4 weeks, then 45 mg every 12 weeks, consider discontinuation if no response within 28 weeks.
- **Child 6-17 years (body-weight 101 kg and above)** (By subcutaneous injection): Initially 90 mg, then 90 mg after 4 weeks, then 90 mg every 12 weeks, consider discontinuation if no response within 28 weeks.
Cautions
Development of malignancy; elderly; history of malignancy; predisposition to infection; start appropriate treatment if widespread erythema and skin exfoliation develop, and stop ustekinumab treatment if exfoliative dermatitis suspected Cautions, further information Tuberculosis Active tuberculosis should be treated with standard treatment for at least 2 months before starting ustekinumab. Patients who have previously received adequate treatment for tuberculosis can start ustekinumab but should be monitored every 3 months for possible recurrence. In patients without active tuberculosis but who were previously not treated adequately, chemoprophylaxis should ideally be completed before starting ustekinumab. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with ustekinumab.
Contraindications
Active infection
Side effects
Common or very common Arthralgia; asthenia; back pain; diarrhoea; dizziness; headache; increased risk of infection; myalgia; nausea; oropharyngeal pain; skin reactions; vomiting Uncommon Depression; facial paralysis; hypersensitivity (may be delayed); nasal congestion Rare or very rare Cutaneous lupus erythematosus; hypersensitivity vasculitis; interstitial lung disease; lupus-like syndrome; pneumonia eosinophilic Frequency not known Increased risk of cancer; meningitis listeria; tuberculosis reactivation
Interactions
**Other interactions (7):**
- Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are...
- If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
- In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen,...
- The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease...
- In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
- In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab.
Pregnancy
Avoid.
Breast feeding
Specialist sources indicate use with caution; negligible amounts present in milk which are likely to be destroyed in the infant's gastro-intestinal tract. In newborn or premature infants there may be greater intestinal absorption.
Medicinal forms
Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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